Many biotech companies have a strong research base but lack the knowledge and experience needed to bring their products closer to the market. LINK Medical Research can help to map the strategic pathway.
Biotech companies with high scientific competence can often get lost along the journey through clinical trials and on towards patients. They lack a road map and expertise in several areas, which is wholly avoidable, according to Gunnar Danielsson, Senior Regulatory Advisor at LINK Medical Research.
- They don’t sit down and do a proper TPP, that is, a map of where you are going and the order in which you will do things in. Instead, many take a trial-and-error route, which can be fun but extremely expensive and ineffective.
- Not having a clear vision also makes it difficult to communicate with others, not least investors, adds Rikard Reneland, Medical Director at LINK Medical Research.
Expertise is needed in 20-30 areas
Putting together a strategic plan requires competence in 20-30 different areas of expertise. It’s rarely the case that a startup with 2-3 people has all the knowledge needed in house.
- A common shortcoming is around how to scale up from the research to the clinical phase. It’s one thing to produce a small amount of product in a lab, but to scale up requires a partner. It takes time and long negotiations; amongst other things, the manufacturer must have the right capabilities and authorisations, explains Rikard Reneland.
- Another key area where biotech companies often lack knowhow is the regulatory requirements for conducting clinical trials, with varying rules in place around the world. If everything isn’t exactly right the authorities will simply send your application back and, before you know it, you’ve lost 6 months, says Gunnar Danielsson.
LINK Medical Research offers a strategic partnership; understanding the risks and challenges biotech companies face on the road through the clinical trial phases until the product is on the market. The Strategic Advisory Group draws together experts from key disciplines and offers companies an initial free consultation, highlighting gaps and helping develop a strategic plan.
“Together, we can give a complete picture of what’s needed and where to go to make sure that nothing is missed,” says Rikard Reneland.
The right track at the right time
It’s not unusual for results to point in new directions, which requires a degree of flexibility. A classic example is Viagra, initially tested as a treatment for heart problems before a side effect was picked up.
There are many famous examples of learning new things along the way, counter to preconceptions. We help companies to stay on the right track throughout their product development journey. It’s not good to jump on a fast train that’s going in the wrong direction, concludes Gunnar Danielsson.
LINK Medical Research is a strategic partner and expert in clinical studies and product development providing services to the pharmaceutical and medical technology industries. LINK Medical’s expertise ranges from early-stage product development to post-marketing support. The company has 200 employees and offices in the Nordic countries, the UK and Germany.